Articles Posted in Personal Injury Litigation

Earlier this week the U.S. Food and Drug Administration reclassified transvaginal mesh implants, which are used to treat female pelvic organ prolapse as high-risk devices. These products must now go through a stringent approval process before being marketed and sold. Vaginal mesh products have contributed to serious complications in women, resulting in erosion and organ perforation, and causing many complaints by patients of pain and severe infection. The implants are now classified as a Class III devices. Thus, the FDA now needs to have more than just written support of the products’ safety as “substantially equivalent” to a product already approved by the FDA in order to be used and sold.

Vaginal mesh devices were previously approved through a much more lenient process in 2002 as Class II medical devices, meaning that several companies, including Johnson & Johnson’s unit Ethicon Inc. and Boston Scientific Corp, among others, were not required to perform any type of clinical testing to support the safety of the devices prior to releasing them on the market. The current cases against Ethicon, now numbering more than 23,000, allege that Ethicon did not provide adequate warnings of the dangers and severe risks of the devices when used to treat pelvic organ prolapse in women. The new requirements give companies that are already making the products about two and a half years to submit their premarket approval application while companies introducing new transvaginal mesh devices for pelvic organ prolapse must submit a premarket approval application before marketing the devices.

This reclassification was undertaken with hopes that it will help address the major risks associated with the surgical mesh implant, and ultimately to improve the lives of women suffering from pelvic organ prolapse. William Maisel, chief scientist for the FDA’s Center for Devices and Radiological Health, said in a statement Monday, “We intend to continue monitoring how women with this device are faring months and years after surgery through continued postmarket surveillance measures.”

Bahe Cook Cantley & Nefzger is currently offering free case evaluations to men who may have suffered cardiac problems due to their use of testosterone therapy medications, such as AndroGel.

More than 2,200 cases have been filed on behalf of men who have suffered heart attacks, strokes, and other cardiovascular complications after using testosterone replacement medications.  These cases are currently pending in a Multi-District litigation in the U.S. District Court for the Northern District of Illinois against both manufacturers and distributors of the Low-T drugs.  The lawsuits allege strict liability for design defects and failure to properly warn consumers, as well as negligence, breach of warranty, fraud, and unjust enrichment, among other things.

On March 3, 2015 the U.S. Food & Drug Administration ordered manufacturers of prescription Low-Testosterone medications to modify their labeling practices in two ways.  First, the labels must include a warning of the association between using testosterone replacement therapy and an increased risk of heart attack and stroke.  Second, the labels must clearly state that the drugs have not been proven safe or effective for treating low testosterone levels in aging men.

With the Takata airbag recall continuing to grow, it is by far the largest auto recall in U.S. history. This not only means that millions of Americans are being affected, but millions are also living in fear that their vehicles may be equipped with the explosive airbags.

That fear may soon come to an end. SafeCar has announced that all vehicle identification numbers (VINs) affected by the recall are now loaded into a Lookup Tool on their website, SafeCar.gov.

Not only is this tool free to the public, but it also produces results within seconds and will inform consumers about all open recalls on their vehicle. SafeCar has also created a video which explains what to expect if your car is recalled and what you should do next.

Kentucky State Police investigators say the Stanford Police Department officer who hit a pedestrian with his cruiser last winter was determined to be traveling at a high rate of speed at the time, but will not be facing criminal charges.

The Lincoln County coroner says Howard Robbins, 69, of Crab Orchard, was walking along KY150 on the night of Jan. 15 when Officer Travis Richardson hit him. EMS took Robbins to the Hospital where he was pronounced dead.

According to the Interior Journal, KSP say Richardson was traveling 90 mph when he hit Robbins. The speed limit is 55 mph in that area. While Officer Richardson was not on duty, he was on his way to work at the time of the collision. The cruiser’s dash-cam captured the wreck. This assisted the police with their investigation.

Bourbon County Middle School’s first day back after the Memorial Day Holiday was a somber one. It was the first day back after a tragic car wreck claimed the life of one of their fellow classmates.

13-year-old Emily Sams was killed in a car crash Saturday morning. The crash occurred on I-64 in Scott County, Kentucky. Emily, along with her mother and father, were in their pickup truck when a Camry ran off the road, overcorrected, and struck the Sams’ vehicle. Both vehicles rolled and Emily was ejected.

The Scott County Coroner told LEX 18 that Emily was not wearing a seatbelt at the time of the accident. Her mother is in critical condition at UK hospital and her father appears to be stable. Those in the Camry were not injured.

I-75 was shut down for more than 9 hours on Tuesday. Around 11:15 p.m. it was finally reopened. The cause of the closure was a horrific accident involving six tractor-trailers and one car, which resulted in two deaths. Janet Montgomery, who was inside one of the six tractor trailers, said of the accident, “You don’t see stuff like this every day, it’s not something that you want to see.”

Kentucky State Police Vehicle Enforcement said the cause of the crash has not been determined, but it appears to have happened when traffic slowed in a construction zone. The last to hit was a FedEx semi, which burst into flames and killed the driver, 41-year-old Toby Caudill of Glenford, Ohio.

In the middle of the six tractor trailers was a car. The operator of the car, 34-year-old Jonathan Roark, was pronounced dead on the scene. He was a military man from the Barbourville area. A third driver was injured in the collision and was taken to the hospital with minor injuries.

Troopers are investigating a two-vehicle accident in Madison County where one person died and several others were injured.

Jacks Creek Road was shut down from 5 pm into the late evening hours, on Tuesday, as investigators reconstructed the accident.

According to Kentucky State Police, one car, with two men and two women, was heading east toward Richmond when it crashed into another car with only one person in it.  The woman in the passenger seat of the first car was pronounced dead on the scene. Police say another person from that same vehicle had to be flown to UK hospital. The three others involved went to the hospital by ambulance.

3 Metcalfe County High School Students were involved in a crash on Friday, 5/15. This crash tragically ended in one death, and left two others in the hospital.

According to Police, around 7:30 am, 17-year-old Jacob White went off the road and over corrected his vehicle, causing it to flip. Passenger, 15-year-old Trevor Meadows, was ejected from the vehicle and taken to the hospital, along with one additional passenger, Jackson Colby Blair.  The driver, Jacob White died at the scene.

This is a devastating reminder of the need to operate our vehicles in the safest manner possible. Although it appears that driver error is to blame here, a full and complete investigation is required to determine any potential causes, such as whether mechanical failure and defective equipment or parts, played any role. The survivors, as well as the friends and family of those killed, will want and deserve answers. If it is determined that the driver was not operating the vehicle with reasonable care, he may be liable for damages and claims against his estate may be brought by the survivors.

A 7-year-old girl was dragged over 1,000 feet by her school bus on Friday. After getting off the bus, the girl’s backpack got snagged in the door of the bus which proceeded to drive away from where it had dropped her off, dragging her behind it. A neighbor’s surveillance camera caught the incident on tape.

A driver in a red Camaro saw the incident occur and sped to the front of the bus to warn the driver. One witness said the girl hardly had any skin left on one of her legs. Once the bus stopped, the girl was rushed to Kosair Children’s Hospital with non-life threatening injuries.

If the bus driver is found to have breached his or her standard of care in operating the bus in a safe and reasonable manner, then he or she could be civilly liable under a theory of negligence for the injuries that resulted.

Transvaginal mesh is an implant typically manufactured with a plastic material called polypropylene.  The product was created to repair conditions such as pelvic organ prolapse and stress urinary incontinence.  The mesh was used fairly commonly to treat women over the past two decades until several products were recalled in the summer of 2011.

Last month Federal District Judge Goodwin was tasked with a legally complex analysis regarding the applicability of punitive damages in the case against Boston Scientific.  While civil litigation is not typically fashioned to impose a penalty on defendants, under limited circumstances a civil defendant may be forced to pay punitive damages above and beyond the compensatory damages calculated to make the plaintiff whole.   These damages are often imposed when defendants had express, direct knowledge that their misconduct could cause injury, and continued the acts nonetheless.

In denying the Defendant’s Motion for Summary Judgment on the issue, Judge Goodwin concluded that a reasonable jury could find Boston Scientific acted with reckless and/or conscious disregard of the health and safety of its consumers, and therefore, summary judgment was inappropriate.   Judge Goodwin also concluded that a reasonable jury could find that the Defendant knew its product would probably cause injury to another person, and placed it in the stream of commerce anyway.